Citalopram Molteni

Package leaflet: Information for the patient

CITALOPRAM MOLTENI 20 mg film-coated tablets, 40 mg film-coated tablets

Citalopram bromide
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Citalopram Molteni is and what it is used for
2. What you need to know before taking Citalopram Molteni
3. How to take Citalopram Molteni
4. Possible side effects
5. How to store Citalopram Molteni
6. Contents of the pack and other information

1. What Citalopram Molteni is and what it is used for

Citalopram Molteni contains the active substance citalopram hydrobromide, which belongs to a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs) that work by regulating mood.
This medicinal product is indicated for the treatment of:

• depression (endogenous depressive syndromes), and for the prevention of relapses and recurrent depressive episodes;
• panic attacks (anxiety disorders with panic attacks), including those caused by fear of open spaces (agoraphobia).

2. What you should know before taking Citalopram Molteni

Do not take Citalopram Molteni in the following cases:

• You are allergic to citalopram hydrobromide or to any of the other ingredients of this medicine (listed in section 6);
• You are under 18 years of age;
• You are taking medicines for depression called monoamine oxidase inhibitors (MAOIs): it may be necessary to wait up to 14 days after stopping treatment before starting therapy with Citalopram Molteni. If you stop taking Citalopram Molteni and need to start treatment with an MAOI, at least 7 days must pass;
• You are taking selegiline, a monoamine oxidase inhibitor used for Parkinson’s disease, at doses exceeding 10 mg per day;
• You are taking linezolid, a medicine used to treat infections, unless your doctor carefully monitors your blood pressure;
• You are taking pimozide, a medicine used to treat certain mental disorders (see section “Other medicines and Citalopram Molteni”);
• You are taking medicines that may cause a disturbance in heart rhythm (prolongation of the QT interval);
• You have or have previously had a heart rhythm disorder (QT interval prolongation or congenital long QT syndrome);
• You are pregnant or breastfeeding, except in the cases listed in section “Pregnancy, breastfeeding and fertility”.

Warnings and precautions
Talk to your doctor or pharmacist before taking Citalopram Molteni.
Use in children and adolescents under 18 years of age
This medicine is contraindicated in children and adolescents under 18 years of age. However,
your doctor may prescribe Citalopram Molteni to patients under 18 years of age if they consider it
the best option for them. In such cases, you must immediately inform your doctor if suicide attempts, suicidal thoughts or hostility (aggression, hostile behaviour and anger) occur during treatment with Citalopram Molteni.
Citalopram Molteni should be used with caution if:

• You suffer from panic disorders, as anxiety symptoms may worsen at the beginning of treatment (paradoxical anxiety). These symptoms usually diminish within the first two weeks;
• You are an elderly woman (over 65 years of age), because in rare cases blood sodium levels may decrease (hyponatraemia). This effect is generally reversible after discontinuation of therapy (see section 4. Possible side effects);
• You suffer from bipolar disorder (manic-depressive illness), because during treatment a shift into the manic phase may occur. In this case, your doctor may decide to discontinue treatment;
• You suffer from epilepsy or seizures: in this case, your doctor will monitor you closely. If seizures occur or their frequency increases, treatment must be discontinued;
• You have diabetes: your doctor may need to adjust the dosage of insulin or your oral antidiabetic medicine;
• Symptoms such as agitation, tremor, muscle twitching (myoclonus) and fever (hyperthermia) occur, as these are early signs of so-called “serotonin syndrome”. In this case, you must consult your doctor immediately, who will advise you to stop treatment with Citalopram Molteni immediately and start symptomatic therapy;
• You are taking medicines such as sumatriptan or other triptans, tramadol, oxitriptan and tryptophan (see “Other medicines and Citalopram Molteni”);
• You are taking medicines that increase the risk of bleeding, such as anticoagulants, because bleeding may occur (see “Other medicines and Citalopram Molteni”), or if you are pregnant (see section “Pregnancy”);
• You are undergoing electroconvulsive therapy (ECT);
• You are taking herbal products containing St. John’s wort (Hypericum perforatum). See “Other medicines and Citalopram Molteni”;
• You suffer from psychotic disorders with depressive episodes, as psychotic symptoms may worsen;
• You have or have had heart problems (QT interval prolongation and Torsade de Pointes), have recently had an acute myocardial infarction, have low levels of potassium or magnesium in the blood (hypokalaemia and hypomagnesaemia), or if signs of cardiac rhythm disturbances (cardiac arrhythmia) occur during treatment;
• You have a condition caused by increased pressure within the eye (narrow-angle glaucoma).

Medicines such as Citalopram Molteni, the so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs), may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
Other medicines and Citalopram Molteni
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription, because Citalopram Molteni may affect how some medicines work or because other medicines may affect how Citalopram Molteni works.
Do not take Citalopram Molteni if you are taking:

• Medicines used to treat depression called monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants, because serious, potentially fatal side effects may occur, including “serotonin syndrome” (see sections “Warnings and precautions” and “Possible side effects”);
• Linezolid, a medicine used to treat bacterial infections;
• Other medicines for bacterial infections (antimicrobials, e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine);
• Selegiline at doses exceeding 10 mg per day, used for the treatment of Parkinson’s disease;
• Medicines used for heart rhythm disorders (class IA and III antiarrhythmics);
• Medicines used to treat mental disorders (phenothiazine antipsychotics, pimozide, haloperidol, risperidone, thioridazine);
• Medicines used to treat malaria (antimalarials, e.g. halofantrine);
• Medicines used to treat allergies (antihistamines, e.g. astemizole and mizolastine).

Avoid taking this medicine together with:
sumatriptan and other triptans, used to treat headache (migraine);
tramadol, used to treat pain,
because they may increase the effects of Citalopram Molteni.
Take this medicine with caution and inform your doctor if you are taking:
selegiline at doses less than 10 mg per day for the treatment of Parkinson’s disease;
lithium and tryptophan for the treatment of certain mental disorders. In this case, your doctor must
perform periodic checks of lithium blood levels;

• Herbal products for depression containing St. John’s wort (Hypericum perforatum);
• Medicines used to make the blood less likely to clot (anticoagulants), medicines affecting platelet function, such as non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, dipyridamole, medicines used to treat mental disorders (atypical antipsychotics, phenothiazines), some medicines for depression (tricyclic antidepressants), because the risk of bleeding (haemorrhage) may increase;
• Medicines that may cause disturbances in heart rhythm (prolongation of the QT interval) or that cause a reduction in potassium or magnesium levels in the blood (hypokalaemia/hypomagnesaemia), because they may increase the risk of developing heart rhythm disorders (malignant arrhythmias);
• Medicines used to treat heart rhythm disorders (flecainide, propafenone);
• Metoprolol, used to treat heart problems (heart failure);
• Medicines used to treat depression (SSRIs and tricyclic antidepressants, bupropion), medicines for certain mental disorders (phenothiazines, thioxanthenes and butyrophenones), tramadol, used to treat severe pain, and mefloquine, used to treat malaria, because they may trigger seizures;
• Other medicines used to treat depression (desipramine, clomipramine and nortriptyline);
• Medicines for gastric ulcers (cimetidine, omeprazole, esomeprazole, lansoprazole), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant) and ticlopidine (used to reduce stroke risk). These may cause an increase in blood levels of citalopram.

Citalopram Molteni with food, drinks and alcohol
Avoid drinking alcoholic beverages during treatment with this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Citalopram Molteni if you are pregnant, especially during the third trimester, except in cases of absolute necessity and under strict medical supervision (see section “Do not take Citalopram Molteni”). If you take this medicine during pregnancy, avoid abruptly stopping treatment (see section “If you stop taking Citalopram Molteni”).
If you take Citalopram Molteni close to the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (tendency to bleed). Inform your doctor or midwife that you are taking Citalopram Molteni so they can advise you on what to do.
Breastfeeding
Do not take this medicine if you are breastfeeding, because citalopram passes into breast milk.
Male fertility
This medicine may affect sperm quality. This effect disappears after discontinuation of treatment.
Driving and using machines
CITALOPRAM Molteni may impair your ability to drive or operate machinery because it may reduce your judgment and reactivity in dangerous situations.
Citalopram Molteni contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Citalopram Molteni

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Swallow the tablets with a glass of water after meals.

Treatment of depression
The recommended dose is 20 mg once daily, as a single dose.
Your doctor may increase the dose up to a maximum of 40 mg daily, depending on your response to the medicine.
The effect of the medicine appears after 2–4 weeks from the start of treatment.
Your doctor will monitor you until symptoms have completely disappeared.
Continue treatment for at least 4–6 months. If you suffer from recurrent unipolar depression, i.e. alternating periods of well-being and depressive episodes, maintenance therapy should be continued for longer periods to prevent relapses.

Treatment of panic attacks
The initial dose for the first week of treatment is 10 mg daily.
Thereafter, your doctor will increase the dose to 20 mg daily, up to a maximum of 40 mg daily, depending on your response to the medicine.
The maximum effect of the medicine appears after 3 months of treatment.
If you suffer from anxiety disorders with panic attacks, treatment should be continued long-term (1 year).
If you have difficulty falling asleep (insomnia) or are very restless, your doctor may also prescribe sedative medicines.

Use in elderly patients
If you are over 65 years of age, your doctor should prescribe a lower dose (10–20 mg daily). The maximum recommended dose is 20 mg daily.

Use in patients with liver problems
If you have mild or moderate liver problems (mild or moderate hepatic insufficiency), the initial dose for the first two weeks is 10 mg daily. Thereafter, your doctor may increase the dose up to a maximum of 20 mg daily, depending on your response to the medicine.
If you have severe liver problems (severely reduced liver function), your doctor may decide to further reduce the dose.

Use in patients with metabolic disorders (poor metabolizers of CYP2C19)
If you have been diagnosed with reduced activity of the liver enzyme CYP2C19, the initial dose for the first two weeks is 10 mg daily. Thereafter, your doctor may increase the dose up to a maximum of 20 mg daily, depending on your response to the medicine.

Use in patients with kidney problems
If you have kidney problems (renal insufficiency), your doctor will prescribe the lowest recommended dose.

If you take more Citalopram Molteni than you should
In case of accidental ingestion/overdose of Citalopram Molteni, contact your doctor immediately or go to the nearest hospital.
Overdose of this medicine may cause one or more of the following symptoms:
seizures, increased heart rate (tachycardia), drowsiness, disturbances in heart rhythm (QT interval prolongation, torsade de pointes, atrioventricular arrhythmia), coma, vomiting, tremor, low blood pressure (hypotension), cardiac arrest, nausea, serotonin syndrome (high fever, tremors, muscle contractions and anxiety), agitation, reduced heart rate (bradycardia), dizziness, conduction block in the heart (bundle branch block), changes in heart activity (ECG abnormalities, QRS prolongation), high blood pressure (hypertension), pupil dilation (mydriasis), stupor, sweating, bluish discoloration of the skin (cyanosis), increased breathing rate (hyperventilation), muscle damage (rhabdomyolysis), fatigue, weakness, sedation.

If you forget to take Citalopram Molteni
Do not take a double dose to make up for the missed tablet.
Take only the next dose at your usual time.

If you stop taking Citalopram Molteni
Do not stop using this medicine abruptly, as within the first few days after discontinuation the following symptoms may occur:
dizziness, sensory disturbances (such as tingling sensations in arms and legs (paresthesia) and electric shock sensations), sleep disturbances such as difficulty falling asleep (insomnia) and vivid dreams, agitation or anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhoea, increased awareness of heartbeats (palpitations), emotional instability, irritability and visual disturbances.
These symptoms are usually mild or moderate in severity and resolve spontaneously within 2 weeks, although sometimes they may be severe and last for a long time (2–3 months or more).
Discontinuation of treatment should be done under medical supervision, with doses gradually reduced over 1–2 weeks or several months, if necessary.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

The following side effects may occur, usually mild and temporary, particularly during the first or second week of treatment:

Very common (may affect more than 1 in 10 people)

• drowsiness, difficulty sleeping (insomnia), headache;
• dry mouth and nausea;
• increased sweating.

Common (may affect up to 1 in 10 people)

• decreased appetite, weight loss;
• agitation, reduced sex drive (libido), anxiety, nervousness, confusion (confusional state), abnormal orgasm in women, abnormal dreams;
• tremor, tingling sensation in arms and legs (paraesthesia), dizziness, attention disturbances;
• perception of ringing in the ear (tinnitus);
• yawning;
• diarrhoea, vomiting, constipation;
• itching;
• muscle pain, joint pain;
• sexual dysfunction in men (impotence, ejaculation disorders, failure to ejaculate);
• fatigue.

Uncommon (may affect up to 1 in 100 people)

• increased appetite, weight gain;
• aggression, feeling detached from oneself (depersonalisation), hallucinations, feeling of excitement (mania);
• fainting accompanied by temporary loss of consciousness (syncope);
• dilation of the pupil (mydriasis);
• decreased or increased heart rate (bradycardia or tachycardia);
• skin irritation (urticaria, rash), hair loss (alopecia), development of red spots on the skin and bleeding (purpura), excessive sensitivity to sunlight (photosensitivity reaction);
• difficulty urinating (urinary retention);
• heavy and prolonged bleeding during menstrual cycle (menorrhagia);
• swelling due to fluid accumulation (oedema).

Rare (may affect up to 1 in 1,000 people)

• reduced levels of sodium in the blood (hyponatraemia);
• seizures, severe epileptic fits (grand mal), involuntary movements (dyskinesia), taste disturbances;
• bleeding (haemorrhage);
• liver inflammation (hepatitis);
• fever (pyrexia).

Frequency not known (frequency cannot be estimated from the available data):

• reduced number of platelets in the blood (thrombocytopenia);
• allergic reactions (hypersensitivity), including severe reactions (anaphylactic reaction);
• changes in levels of the hormone regulating urine production (inappropriate antidiuretic hormone secretion);
• reduced levels of potassium in the blood (hypokalaemia);
• panic attacks, teeth grinding (bruxism), restlessness, suicidal thoughts (suicidal ideation), suicidal behaviour;
• seizures, serotonin syndrome (high fever, tremors, muscle contractions and anxiety), extrapyramidal disorders such as involuntary movements, tremors, muscle rigidity and contractions, feeling of restlessness and inability to remain in the same position even for a very short time (akathisia), other movement disorders;
• visual disturbances;
• disturbances in heart rhythm (QT interval prolongation, ventricular arrhythmias, including torsade de pointes), particularly in women with low potassium levels in the blood (hypokalaemia) or those who already suffer from heart rhythm disorders (pre-existing QT interval prolongation) or other heart conditions (cardiac diseases);
• sensation of dizziness when standing up quickly, caused by a drop in blood pressure (orthostatic hypotension);
• nosebleeds (epistaxis);
• bleeding from the stomach or intestine (gastrointestinal haemorrhage, including rectal bleeding);
• abnormal liver function tests;
• bruising, swelling of the face, lips, mouth, tongue or throat due to fluid accumulation (angioedema);
• irregular menstrual cycle (metrorrhagia);
• prolonged and painful erection in men (priapism), sudden milk production from the breast in men (galactorrhoea);
• increased levels of prolactin hormone in the blood (hyperprolactinaemia);
• heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, "Pregnancy", for further information.

Following the use of Citalopram and other medicines used to treat depression known as tricyclic antidepressants (TCAs), an increased risk of bone fractures has been reported.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Citalopram Molteni

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Citalopram Molteni contains
Citalopram Molteni 20 mg film-coated tablets

• The active substance is citalopram hydrobromide. Each tablet contains 24.98 mg of citalopram hydrobromide (equivalent to 20 mg of citalopram base).
• The other ingredients are: maize starch, monohydrate lactose, sodium croscarmellose, glycerol, copovidone, magnesium stearate, microcrystalline cellulose, hypromellose, macrogol 400, titanium dioxide.

Citalopram Molteni 40 mg film-coated tablets

• The active substance is citalopram hydrobromide. Each tablet contains 49.96 mg of citalopram hydrobromide (equivalent to 40 mg of citalopram base).
• The other ingredients are: maize starch, monohydrate lactose, sodium croscarmellose, glycerol, copovidone, magnesium stearate, microcrystalline cellulose, hypromellose, macrogol 400, titanium dioxide.

Description of the appearance of Citalopram Molteni and package contents
Citalopram Molteni 20 mg film-coated tablets
20 mg film-coated tablets. Carton pack containing 14 or 28 tablets.
Citalopram Molteni 40 mg film-coated tablets
40 mg film-coated tablets. Carton pack containing 14 tablets.

Marketing Authorization Holder
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. – Strada Statale 67 Fraz. Granatieri –
Scandicci (FI) – Italy

Manufacturers
Istituto de Angeli srl – Località Prulli – 50066 Reggello (FI) – Italy
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. – Strada Statale 67 Fraz. Granatieri –
Scandicci (FI) – Italy
Fine Foods & Pharmaceuticals N.T.M. SpA Via Grignano 43, Brembate (BG) – Italy